EP1585558B1 - Apparatus for lancet actuation - Google Patents
Apparatus for lancet actuation Download PDFInfo
- Publication number
- EP1585558B1 EP1585558B1 EP03749517.3A EP03749517A EP1585558B1 EP 1585558 B1 EP1585558 B1 EP 1585558B1 EP 03749517 A EP03749517 A EP 03749517A EP 1585558 B1 EP1585558 B1 EP 1585558B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- lancet
- interface
- lancing
- processor
- driver
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
- A61B5/15165—Piercing elements stocked in or on a strip
- A61B5/15169—Characterized by a rolled strip
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- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
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- A61B5/15171—Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
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- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
- A61B5/15174—Piercing elements stocked in the form of a stack or pile
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- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15176—Stocking means comprising cap, cover, sheath or protection for aseptic stocking
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- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15184—Piercing device comprising a separate compartment or unit for used piercing elements
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- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
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- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
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- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
- A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
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- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
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- A61B17/32093—Incision instruments for skin incisions
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- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150083—Means for enhancing collection by vibration, e.g. ultrasound
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
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- B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0627—Sensor or part of a sensor is integrated
- B01L2300/0663—Whole sensors
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- B01L2300/18—Means for temperature control
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
- G01N33/4905—Determining clotting time of blood
Definitions
- Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis.
- Biochemical analysis of blood samples is a diagnostic tool for determining clinical information.
- Many point-of-care tests are performed using whole blood, the most common being monitoring diabetic blood glucose level.
- Other uses for this method include the analysis of oxygen and coagulation based on Prothrombin time measurement.
- a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin.
- lancing devices that contain a multitude of spring, cam and mass actuators to drive the lancet. These include cantilever springs, diaphragms, coil springs, as well as gravity plumbs used to drive the lancet.
- the device is pre-cocked or the user cocks the device. The device is held against the skin and the user, or pressure from the users skin, mechanically triggers the ballistic launch of the lancet. The forward movement and depth of skin penetration of the lancet is determined by a mechanical stop and/or dampening, as well as a spring or cam to retract the lancet.
- Such devices have the possibility of multiple strikes due to recoil, in addition to vibratory stimulation of the skin as the driver impacts the end of the launcher stop, and only allow for rough control for skin thickness variation. Different skin thickness may yield different results in terms of pain perception, blood yield and success rate of obtaining blood between different users of the lancing device.
- Success rate generally encompasses the probability of producing a blood sample with one lancing action, which is sufficient in volume to perform the desired analytical test.
- the blood may appear spontaneously at the surface of the skin, or may be "milked" from the wound. Milking generally involves pressing the side of the digit, or in proximity of the wound to express the blood to the surface. In traditional methods, the blood droplet produced by the lancing action must reach the surface of the skin to be viable for testing.
- Another problem frequently encountered by patients who must use lancing equipment to obtain and analyze blood samples is the amount of manual dexterity and hand-eye coordination required to properly operate the lancing and sample testing equipment due to retinopathies and neuropathies particularly, severe in elderly diabetic patients. For those patients, operating existing lancet and sample testing equipment can be a challenge. Once a blood droplet is created, that droplet must then be guided into a receiving channel of a small test strip or the like. If the sample placement on the strip is unsuccessful, repetition of the entire procedure including relancing the skin to obtain a new blood droplet is necessary.
- GB 2 335 990 A discloses a hypodermic needle having an electrical impedance sensor for sensing penetration depth.
- the device has a shaft that can sense the depth of penetration into an object (the substrate).
- the substrate being penetrated has impedance that varies according to the depth under a surface of the substrate.
- the shaft has a tip for penetration and has conductive ends near to the tip of the shaft.
- a change of impedance of material of the object between the conductive ends can be sensed to provide information on the depth of penetration.
- a processor can be provided external to the object being penetrated by the shaft to gather and process the impedance information to determine whether the desired depth has been achieved.
- US 5 830 219 discloses an apparatus for holding and driving a rotary cutting surgical instrument with a needle guiding stage of a stereotactic mammography biopsy system.
- the system includes a rotary cutting surgical instrument having a housing with a mechanism for securing the housing to a needle guiding stage of the stereotactic mammography biopsy system.
- the apparatus further includes a position encoder and controller for determining the resistance experienced by the rotary cutting instrument and for controlling the rotation of the instrument in response to the resistance.
- US 6 423 014 discloses a needing device and methods for mechanically effecting needling procedures according to predetermined parameters and/or measuring the physical and/or electrical characteristics of such needling procedures.
- US 6 364 889 discloses the use of a substantially free-standing voice coil within a lancing device in coordination and combination with a stationary magnet and electronic circuit.
- the minimal weight of the free standing voice coil and the attractive forces of the magnet are said to allow a battery-powered electronic circuit to maintain excellent control over the advancement and retraction of a lancet.
- the voltage source within the electronic lancing device provides current through the voice coil such that the coil and lancet are repulsed from the magnet and propelled into the puncture site.
- the voltage source subsequently reverses the current through the voice coil to supply sufficient attractive current through the voice coil such that the dwell time of the lancet is minimized and the lancet is retracted from the puncture site and pulled toward the magnet within the housing of the electronic lancing device.
- EP 0 898 936 discloses a blood sampling device provided with a housing, a lancet assembly, a lancet holder disposed in the housing for supporting the lancet assembly, the lancet holder being movable in a lancing direction between a cocked position and a puncture position, a drive spring for forcing the lancet holder from the cocked position to the puncture position, and a mechanism for damping movement of the lancet holder during travel of the lancet holder from the puncture position to an intermediate position between the puncture position and the cocked position.
- the damping mechanism may be provided in the form of a non-planar surface, such as a corrugated surface, disposed on the lancet holder and a damping member which makes contact with the non-planar surface during movement of the lancet holder.
- US 2003/083686 discloses a tissue penetration device and method of using the same.
- the device optionally includes sampling and analysing functions.
- An example provides control of a lancet for sampling blood using electric field coils or solenoids to drive the lancet. Advancement and retraction of the lancet is controlled by a feedback loop monitoring the position and velocity of the lancet and may be configured to follow a predetermined tissue lancing profile.
- one embodiment of the present invention may comprise a lancet driver 1000 configured to exert a driving force on a lancet 1002 and used on a tissue site 234.
- the lancet driver 1000 uses a drive force generator 1004 such as, but not limited to, , a linear voice coil device, or rotary voice coil device to advance or actuate the lancet along a path 1006 into a tissue site 234.
- a variety of drive force generators may be used such as voice coil drive force generators, solenoid drive force generators, or similar drive force generators.
- Spring-based drive force generators or other non-electrical force generators may be used in certain alternative examples where the force generators can deliver the lancet at desired speeds while having mechanical dampers, stops, or other apparatus to provide the desired deceleration that minimizes oscillation of the lancet. Additionally, the coil does not need to be fully surrounded by a magnetically active region.
- a sensor 1008 may be used to detect lancet position along the path 1006 during the lancing cycle.
- a suitable sensor may include, but is not limited to, an optical position sensor or the like.
- a suitable sensor may also include those that can provide lancet position and sufficient sensor resolution to provide lancet velocity along the path 1006.
- the sensor 1008 may be positioned such as to detect the position of a drive element that corresponds to or actuates the lancet.
- the sensor 1008 may also be positioned to detect the position of the lancet itself.
- a processor 1020 may be used to support a closed feedback control loop 1022 as indicated by the arrows, to provide lancet control.
- the driver 1000 of Fig. 107 may also include a controller or processor (not shown).
- the control of lancet 1002 may involve lancet position control and may also include lancet velocity control to follow a selectable lancet velocity profile or waveform.
- the processor 1020 will be coupled to the drive force generator 1004 wherein the processor will signal or actuate the generator to drive the lancet at various velocities.
- the lancet velocity profile or waveform may be designed to drive the lancet to minimize pain to a patient while also providing sufficient body fluid or blood yield for sampling purposes.
- the velocity profile specifically in electrically powered force generators, may correspond to the duration and amount of electric current applied to the electrically powered force generators.
- the velocity profile may also provide for programmable deceleration profile of the lancet velocity to provide lancet stopping in the tissue site without a sudden hard stop that increases pain to the patient.
- the lancet velocity profile may used with suitable drive force generators to provide lancet velocities between about 0.8 to 20.0 meter per second on the penetration stroke and lancet velocities of 0.5 meters per second to less than about 0.02 meters per second on the withdrawal stroke.
- the lancet 1002 may be driven along a path towards the tissue site 324, into the tissue site 324, and then withdrawn from the tissue site 324 to draw body fluid into a wound channel created by the lancet.
- the lancet may follow a one directional linear path into the tissue site and follow the same linear path out of the tissue site.
- a voice coil drive force generator 1030 is shown with a mechanical damper 1032 for providing a controlled deceleration as the lancet reaches a desired displacement away from the driver.
- This mechanical damper 1032 may have a drive portion which is electrically actuated.
- Other suitable mechanical dampers may include dashpots using air, liquid or gel, electro- dynamic using eddy currents induced into a conductor with permanent or electromagnets, mechanical stops comprising polymer or elastomeric material minimizing oscillations, or a mechanical catch that holds the lancet in position until it is desired to release the lancet for the withdrawal stroke or some combination of these dampers.
- the damper 1032 may be disposed in a variety of locations on the lancet driver including coupling to the lancet or to the drive components of force generator 1030 (shown in phantom).
- Figures 110A and 110B show examples of a device having a drive force generator 1004 and a multiple lancet device 1040 such as a bandolier.
- the drive force generator 1004 may be, but is not limited to, a voice coil force generator for driving lancet 1042 ( Fig. 110B ).
- the multiple lancet device or cartridge 1040 allows the user to have multiple lancet events without reloading the driver with a new lancet for each lancing event. This reduces the number of steps that a patient performs and thus will reduce the barrier to more frequent blood glucose testing.
- a human interface 1051 such as but not limited to an LCD screen, may be included with the lancet driver 1050.
- the human interface may provide human readable output, human recognizable output (such as flashing indicators, icons, or symbols) or possible audio signals.
- the driver 1050 may also include buttons under software control such as one button 1052 for firing or actuating a lancet. A first press may turn on the driver 1050 and a second press may fire or actuate the lancet.
- present invention may use two processors 1054 and 1056 (shown in phantom), the actuator processor 1054 that is fast and high power and the LCD/Human Interface (HI) processor 1056 that is low power and slower.
- HI LCD/Human Interface
- the HI processor 1056 is in sleep mode and runs intermittently to conserve power.
- the HI processor 1056 controls the power to the actuator processor 1054 as needed. It also is a watchdog timer for the high-speed processor so that it will not remain on for long periods of time and drain the batteries.
- the communications between these two processors 1054 and 1056 uses a few lines and may be, but not necessarily, serial in nature.
- the communications may use a variety of interface standard such as, but not limited to, RS-232, SPI, f C or a proprietary scheme.
- the present example may include at least one interface wire and ground.
- the human interface may provide a variety of outputs such as, but not limited to, stick or lancing event number, lancets remaining, time, alarm, profile information, force in last stick/lancing event, or last stick/lancing event time.
- one example of the driver 1050 may include at least one or a plurality of LED lights 1060 to provide alarms or other information to the user.
- Fig. 113 show a driver having an audio or sound generator for providing alarm or other information to the user.
- Fig. 114 shows the driver with a data interface device 1064 (shown in phantom) for allowing data communications with another support device such as, but not limited to, a computer, PDA, a computer network, a temporary storage device, other device for receiving data from the lancet driver.
- Fig. 115 shows a further example where human interface 1051 is on a separate or separable device that is coupled to the driver 1050 to provide the human interface feature. It should be understood of course, that the human interface may any of those described herein, such as those providing video, audio, other signals.
- the present invention may include one or more buttons so that the user may control the Human Interface.
- One or more output display devices such as, but not limited to, individual LED's, arrays of LED's, LCD panels, buzzers, beepers, vibration, may be used by the user to provide feedback.
- External communications with other data interchange devices like personal computers, modems, personal data assistants, etc. may be provided.
- the human interface may further include but is not limited to, at least one pushbutton, a touch pad independent of the display device, or a touch sensitive screen on the LCD display. Additionally the interface may allow for other functionality such as an interface that allows the user to control the sampling/pain interface setting, or a device that sense whether there is a lancet loaded and ready for use, multiple sampling/pain interface protocols that the user can preset for sampling different areas of the body such as the finger versus the forearm. Additionally, a real time clock and one or more alarms the user can set for reminders of when the next stick is needed.
- the alarms may be individually settable with a master enable/disable that affects all alarms to easily suppress them in restaurants and theaters or other situations where an alarm would be offensive.
- the alarms can be set for blinking light, sound, and vibration or off.
- An enhancement would allow an alarm to be enabled for one or more days. This way the users schedule could be accommodated. For instance an alarm might be set for 10: 00 AM for Monday thru Friday, but turned off Saturday and Sunday in preference to an alarm for 11: 00 AM on those days.
- the HI may have a data recorder function. It may accumulate various data for feedback to the user or another data collection device or network. Some examples of types of data that might be recorded include: the number of lancets used, the number of sticks for this day, the time and date of the last n lancet events, or the interval between alarm and stick, amount of force of the stick, user setting, battery status, etc.
- the HI processor may pass the information to other devices through commonly available data interface devices or interfaces 1064, or optionally a proprietary interface.
- Some common data interface devices or interfaces include but are not limited to : Serial RS-232, modem-interface, USB, HPNA, Ethernet, optical interface, IRDA, RF interface, Bluetooth interface, cellular telephone interface, 2 way pager interface, a-parallel port interface standard, near field magnetic coupling, or other RF network transceiver.
- Serial RS-232 modem-interface
- USB highNA
- Ethernet optical interface
- IRDA IRDA
- RF interface Bluetooth interface
- cellular telephone interface 2 way pager interface
- a-parallel port interface standard near field magnetic coupling
- the interfaces may be compatible with personal computers, modems, PDAs or existing computer networks.
- the positioning of the LCD screen for the human interface may be varied so as to provide the best location for ergonomic use.
- the human interface may be a voice system that uses words to describe status or alarms related to device usage. Expected variations or differences in the results are contemplated in accordance with the objects and practices of the present invention. It is intended, therefore, that the invention be defined by the scope of the claims which follow and that such claims be interpreted as broadly as is reasonable.
Description
- Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis. Biochemical analysis of blood samples is a diagnostic tool for determining clinical information. Many point-of-care tests are performed using whole blood, the most common being monitoring diabetic blood glucose level. Other uses for this method include the analysis of oxygen and coagulation based on Prothrombin time measurement. Typically, a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin.
- Early methods of lancing included piercing or slicing the skin with a needle or razor. Current methods utilize lancing devices that contain a multitude of spring, cam and mass actuators to drive the lancet. These include cantilever springs, diaphragms, coil springs, as well as gravity plumbs used to drive the lancet. Typically, the device is pre-cocked or the user cocks the device. The device is held against the skin and the user, or pressure from the users skin, mechanically triggers the ballistic launch of the lancet. The forward movement and depth of skin penetration of the lancet is determined by a mechanical stop and/or dampening, as well as a spring or cam to retract the lancet. Such devices have the possibility of multiple strikes due to recoil, in addition to vibratory stimulation of the skin as the driver impacts the end of the launcher stop, and only allow for rough control for skin thickness variation. Different skin thickness may yield different results in terms of pain perception, blood yield and success rate of obtaining blood between different users of the lancing device.
- Success rate generally encompasses the probability of producing a blood sample with one lancing action, which is sufficient in volume to perform the desired analytical test. The blood may appear spontaneously at the surface of the skin, or may be "milked" from the wound. Milking generally involves pressing the side of the digit, or in proximity of the wound to express the blood to the surface. In traditional methods, the blood droplet produced by the lancing action must reach the surface of the skin to be viable for testing.
- When using existing methods, blood often flows from the cut blood vessels but is then trapped below the surface of the skin, forming a hematoma. In other instances, a wound is created, but no blood flows from the wound. In either case, the lancing process cannot be combined with the sample acquisition and testing step. Spontaneous blood droplet generation with current mechanical launching system varies between launcher types but on average it is about 50% of lancet strikes, which would be spontaneous. Otherwise milking is required to yield blood. Mechanical launchers are unlikely to provide the means for integrated sample acquisition and testing if one out of every two strikes does not yield a spontaneous blood sample.
- Many diabetic patients (insulin dependent) are required to self-test for blood glucose levels five to six times daily. The large number of steps required in traditional methods of glucose testing ranging from lancing, to milking of blood, applying blood to the test strip, and getting the measurements from the test strip discourages many diabetic patients from testing their blood glucose levels as often as recommended. Tight control of plasma glucose through frequent testing is therefore mandatory for disease management. The pain associated with each lancing event further discourages patients from testing. Additionally, the wound channel left on the patient by known systems may also be of a size that discourages those who are active with their hands or who are worried about healing of those wound channels from testing their glucose levels.
- Another problem frequently encountered by patients who must use lancing equipment to obtain and analyze blood samples is the amount of manual dexterity and hand-eye coordination required to properly operate the lancing and sample testing equipment due to retinopathies and neuropathies particularly, severe in elderly diabetic patients. For those patients, operating existing lancet and sample testing equipment can be a challenge. Once a blood droplet is created, that droplet must then be guided into a receiving channel of a small test strip or the like. If the sample placement on the strip is unsuccessful, repetition of the entire procedure including relancing the skin to obtain a new blood droplet is necessary.
-
GB 2 335 990 A -
US 5 830 219 discloses an apparatus for holding and driving a rotary cutting surgical instrument with a needle guiding stage of a stereotactic mammography biopsy system. The system includes a rotary cutting surgical instrument having a housing with a mechanism for securing the housing to a needle guiding stage of the stereotactic mammography biopsy system. The apparatus further includes a position encoder and controller for determining the resistance experienced by the rotary cutting instrument and for controlling the rotation of the instrument in response to the resistance. -
US 6 423 014 discloses a needing device and methods for mechanically effecting needling procedures according to predetermined parameters and/or measuring the physical and/or electrical characteristics of such needling procedures. -
US 6 364 889 discloses the use of a substantially free-standing voice coil within a lancing device in coordination and combination with a stationary magnet and electronic circuit. The minimal weight of the free standing voice coil and the attractive forces of the magnet are said to allow a battery-powered electronic circuit to maintain excellent control over the advancement and retraction of a lancet. When the electronic lancing device is initiated by a user, the voltage source within the electronic lancing device provides current through the voice coil such that the coil and lancet are repulsed from the magnet and propelled into the puncture site. The voltage source subsequently reverses the current through the voice coil to supply sufficient attractive current through the voice coil such that the dwell time of the lancet is minimized and the lancet is retracted from the puncture site and pulled toward the magnet within the housing of the electronic lancing device. -
EP 0 898 936 discloses a blood sampling device provided with a housing, a lancet assembly, a lancet holder disposed in the housing for supporting the lancet assembly, the lancet holder being movable in a lancing direction between a cocked position and a puncture position, a drive spring for forcing the lancet holder from the cocked position to the puncture position, and a mechanism for damping movement of the lancet holder during travel of the lancet holder from the puncture position to an intermediate position between the puncture position and the cocked position. The damping mechanism may be provided in the form of a non-planar surface, such as a corrugated surface, disposed on the lancet holder and a damping member which makes contact with the non-planar surface during movement of the lancet holder. -
US 2003/083686 discloses a tissue penetration device and method of using the same. The device optionally includes sampling and analysing functions. An example provides control of a lancet for sampling blood using electric field coils or solenoids to drive the lancet. Advancement and retraction of the lancet is controlled by a feedback loop monitoring the position and velocity of the lancet and may be configured to follow a predetermined tissue lancing profile. - Aspects of the invention are set out in the appended claims.
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FIG. 107 is a schematic showing a lancet driver having a driver force generator and a sensor according to the present invention. -
FIG. 108 is a schematic showing one embodiment of the lancet driver using closed loop control. -
FIG. 109 is a schematic showing one example of the lancet driver using a damper. -
FIGS. 110A and110B show examples of the lancet driver for use with multiple lancets. -
FIGS. 111-115 illustrate examples of a lancet driver with a variety of different interface devices. - As illustrated generically in
Figure 107 , one embodiment of the present invention may comprise alancet driver 1000 configured to exert a driving force on alancet 1002 and used on atissue site 234. Thelancet driver 1000 uses adrive force generator 1004 such as, but not limited to, , a linear voice coil device, or rotary voice coil device to advance or actuate the lancet along apath 1006 into atissue site 234. It should be understood that a variety of drive force generators may be used such as voice coil drive force generators, solenoid drive force generators, or similar drive force generators. Spring-based drive force generators or other non-electrical force generators may be used in certain alternative examples where the force generators can deliver the lancet at desired speeds while having mechanical dampers, stops, or other apparatus to provide the desired deceleration that minimizes oscillation of the lancet. Additionally, the coil does not need to be fully surrounded by a magnetically active region. - A
sensor 1008 may be used to detect lancet position along thepath 1006 during the lancing cycle. A suitable sensor may include, but is not limited to, an optical position sensor or the like. A suitable sensor may also include those that can provide lancet position and sufficient sensor resolution to provide lancet velocity along thepath 1006. As discussed above, thesensor 1008 may be positioned such as to detect the position of a drive element that corresponds to or actuates the lancet. Thesensor 1008 may also be positioned to detect the position of the lancet itself. - Referring now to
Fig. 108 , aprocessor 1020 may be used to support a closedfeedback control loop 1022 as indicated by the arrows, to provide lancet control. Thedriver 1000 ofFig. 107 may also include a controller or processor (not shown). The control oflancet 1002 may involve lancet position control and may also include lancet velocity control to follow a selectable lancet velocity profile or waveform. In most embodiments, theprocessor 1020 will be coupled to thedrive force generator 1004 wherein the processor will signal or actuate the generator to drive the lancet at various velocities. - The lancet velocity profile or waveform may be designed to drive the lancet to minimize pain to a patient while also providing sufficient body fluid or blood yield for sampling purposes. The velocity profile, specifically in electrically powered force generators, may correspond to the duration and amount of electric current applied to the electrically powered force generators. The velocity profile may also provide for programmable deceleration profile of the lancet velocity to provide lancet stopping in the tissue site without a sudden hard stop that increases pain to the patient. In specific examples, the lancet velocity profile may used with suitable drive force generators to provide lancet velocities between about 0.8 to 20.0 meter per second on the penetration stroke and lancet velocities of 0.5 meters per second to less than about 0.02 meters per second on the withdrawal stroke.
- The
lancet 1002 may be driven along a path towards the tissue site 324, into the tissue site 324, and then withdrawn from the tissue site 324 to draw body fluid into a wound channel created by the lancet. Although not limited in this manner, the lancet may follow a one directional linear path into the tissue site and follow the same linear path out of the tissue site. - Referring to
Figure 109 , a voice coildrive force generator 1030 is shown with amechanical damper 1032 for providing a controlled deceleration as the lancet reaches a desired displacement away from the driver. Thismechanical damper 1032 may have a drive portion which is electrically actuated. Other suitable mechanical dampers may include dashpots using air, liquid or gel, electro- dynamic using eddy currents induced into a conductor with permanent or electromagnets, mechanical stops comprising polymer or elastomeric material minimizing oscillations, or a mechanical catch that holds the lancet in position until it is desired to release the lancet for the withdrawal stroke or some combination of these dampers. It should also be understood that thedamper 1032 may be disposed in a variety of locations on the lancet driver including coupling to the lancet or to the drive components of force generator 1030 (shown in phantom). -
Figures 110A and110B show examples of a device having adrive force generator 1004 and amultiple lancet device 1040 such as a bandolier. Thedrive force generator 1004 may be, but is not limited to, a voice coil force generator for driving lancet 1042 (Fig. 110B ). The multiple lancet device orcartridge 1040 allows the user to have multiple lancet events without reloading the driver with a new lancet for each lancing event. This reduces the number of steps that a patient performs and thus will reduce the barrier to more frequent blood glucose testing. - Referring now to
Figure 111 , in one example of the present invention, ahuman interface 1051, such as but not limited to an LCD screen, may be included with thelancet driver 1050. It should understood the human interface may provide human readable output, human recognizable output (such as flashing indicators, icons, or symbols) or possible audio signals. Thedriver 1050 may also include buttons under software control such as onebutton 1052 for firing or actuating a lancet. A first press may turn on thedriver 1050 and a second press may fire or actuate the lancet. In one specific embodiment, present invention may use twoprocessors 1054 and 1056 (shown in phantom), theactuator processor 1054 that is fast and high power and the LCD/Human Interface (HI)processor 1056 that is low power and slower. TheHI processor 1056 is in sleep mode and runs intermittently to conserve power. TheHI processor 1056 controls the power to theactuator processor 1054 as needed. It also is a watchdog timer for the high-speed processor so that it will not remain on for long periods of time and drain the batteries. The communications between these twoprocessors - Referring now to
Fig. 112 , one example of thedriver 1050 may include at least one or a plurality ofLED lights 1060 to provide alarms or other information to the user.Fig. 113 show a driver having an audio or sound generator for providing alarm or other information to the user.Fig. 114 shows the driver with a data interface device 1064 (shown in phantom) for allowing data communications with another support device such as, but not limited to, a computer, PDA, a computer network, a temporary storage device, other device for receiving data from the lancet driver.Fig. 115 shows a further example wherehuman interface 1051 is on a separate or separable device that is coupled to thedriver 1050 to provide the human interface feature. It should be understood of course, that the human interface may any of those described herein, such as those providing video, audio, other signals. - In one example, the present invention may include one or more buttons so that the user may control the Human Interface. One or more output display devices such as, but not limited to, individual LED's, arrays of LED's, LCD panels, buzzers, beepers, vibration, may be used by the user to provide feedback. External communications with other data interchange devices like personal computers, modems, personal data assistants, etc. may be provided.
- One function of the human interface is to allow the user to initiate the cycle of the actuator. To allow user input, the human interface may further include but is not limited to, at least one pushbutton, a touch pad independent of the display device, or a touch sensitive screen on the LCD display. Additionally the interface may allow for other functionality such as an interface that allows the user to control the sampling/pain interface setting, or a device that sense whether there is a lancet loaded and ready for use, multiple sampling/pain interface protocols that the user can preset for sampling different areas of the body such as the finger versus the forearm. Additionally, a real time clock and one or more alarms the user can set for reminders of when the next stick is needed. The alarms may be individually settable with a master enable/disable that affects all alarms to easily suppress them in restaurants and theaters or other situations where an alarm would be offensive. The alarms can be set for blinking light, sound, and vibration or off. An enhancement would allow an alarm to be enabled for one or more days. This way the users schedule could be accommodated. For instance an alarm might be set for 10: 00 AM for Monday thru Friday, but turned off Saturday and Sunday in preference to an alarm for 11: 00 AM on those days.
- In some examples, the HI may have a data recorder function. It may accumulate various data for feedback to the user or another data collection device or network. Some examples of types of data that might be recorded include: the number of lancets used, the number of sticks for this day, the time and date of the last n lancet events, or the interval between alarm and stick, amount of force of the stick, user setting, battery status, etc. The HI processor may pass the information to other devices through commonly available data interface devices or
interfaces 1064, or optionally a proprietary interface. Some common data interface devices or interfaces include but are not limited to : Serial RS-232, modem-interface, USB, HPNA, Ethernet, optical interface, IRDA, RF interface, Bluetooth interface, cellular telephone interface, 2 way pager interface, a-parallel port interface standard, near field magnetic coupling, or other RF network transceiver. One use of these interfaces is to move the data to somewhere else so that the user, a doctor, nurse or other medical technician may analyze it. The interfaces may be compatible with personal computers, modems, PDAs or existing computer networks. - While the invention has been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the scope of the invention. For example, the positioning of the LCD screen for the human interface may be varied so as to provide the best location for ergonomic use. The human interface may be a voice system that uses words to describe status or alarms related to device usage. Expected variations or differences in the results are contemplated in accordance with the objects and practices of the present invention. It is intended, therefore, that the invention be defined by the scope of the claims which follow and that such claims be interpreted as broadly as is reasonable.
Claims (5)
- A lancet driver device (1000, 1050) configured to exert a driving force on a lancet (1002)
and used at a tissue site (234) during a lancing cycle, said device comprising:a housing;a controllable drive force generator (1004); an actuator processor (1054) coupled to the drive force generator capable of changing the direction and magnitude of force exerted on the lancet during the lancing cycle;a Human Interface (1051) on said housing wherein the Human Interface is an audio or sound generator for providing alarm or other information to a user of the driver device;an LCD/Human Interface processor (1056) configured to run intermittently and to control power to the actuator processor, wherein the LCD/Human Interface processor has a lower power consumption than the actuator processor; anda position sensor (1008) as part of a feedback loop configured to detect lancet position during the lancing cycle. - The device of claim 1 further comprising a data exchange device (1064) for coupling said lancing device to support equipment.
- The device of claim 1 further comprising a data exchange device (1064) for coupling said lancing device to support equipment selected from one of the following: personal computer, modem, PDA or a computer network.
- The device of claim 1 further comprising a data interface device (1064) for coupling said lancing device to support equipment using a data interface selected from one of the following:Serial RS-232, modem interface, USB, HPNA, IEEE 8023, optical interface, IRDA, RF interface, IEEE 802.15.1, cellular telephone interface, 2 way pager interface, a parallel port interface standard, near field magnetic coupling, or RF transceiver.
- The device of claim 1 further comprising memory for storing at least one of the following:number of lancets used; number of lancing events for this day; time and date of the last N lancing events, wherein N is an integer; or time interval between alarm and lancing event.
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US10/237,261 US7344507B2 (en) | 2002-04-19 | 2002-09-05 | Method and apparatus for lancet actuation |
US237261 | 2002-09-05 | ||
PCT/US2003/028112 WO2004022133A2 (en) | 2002-09-05 | 2003-09-05 | Methods and apparatus for lancet actuation |
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EP1585558A2 EP1585558A2 (en) | 2005-10-19 |
EP1585558A4 EP1585558A4 (en) | 2009-01-07 |
EP1585558B1 true EP1585558B1 (en) | 2016-11-23 |
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EP03749517.3A Expired - Lifetime EP1585558B1 (en) | 2002-09-05 | 2003-09-05 | Apparatus for lancet actuation |
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AU2003268547A8 (en) | 2004-03-29 |
WO2004022133A2 (en) | 2004-03-18 |
US20080194989A1 (en) | 2008-08-14 |
US20080287831A1 (en) | 2008-11-20 |
US20070064516A1 (en) | 2007-03-22 |
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